Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but otherwise healthy male subjects.
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration of Multiple Ascending Doses.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2820 | Active Comparator | AZD2820 multiple injections |
|
| Placebo for AZD2820 | Placebo Comparator | Placebo for AZD2820 multiple injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2820 | Drug | Ascending subcutaneous injections of AZD2820 once daily for 14 days in the abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of the safety and tolerability profile of AZD2820 in terms of adverse events. | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as day 1 of dosing, up to day 29 |
| Description of the safety and tolerability profile of AZD2820 in terms of labolatory data ( clinical chemistry, haematology and urinalisys). | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as one day prior first dose, up to day 28. |
| Description of the safety and tolerability profile of AZD2820 in terms of vital signs ( pulse, systolic and diastolic blood preassure ( SBP, DBP and 24h ambulatory BP), body temperature). | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as one day prior first dose, up to day 29. |
| Description of the safety and tolerability profile of AZD2820 in terms of total immunoglobulin levels. | Number of subjects with immunoglobuline level outsite of reference range. No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as one day prior first dose, up to day 44. |
| Description of the safety and tolerability profile of AZD2820 in terms of safety electrocardiogram (ECG). | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis | From baseline, defined as last pre dose measurement, up to day 28. |
| Description of the safety and tolerability profile of AZD2820 in terms of digital electrocardiogram (ECG). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total caloric intake from baseline. | Change from baseline will be measured after each meal and then grafically presented. | From baseline, defined as one day prior first dose to end of treatement which is day 15. |
| Description of the PK profile of AZD2820 in terms of Cmax, AUC(0-tau), AUC(0-t), AUC, (t1/2lz, h). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Ritter, BM BCH, MRCP, FRCP | QLON | Principal Investigator |
| Mark Berner Hansen, PHD | AstraZeneca Mölndal, Sweden | Study Director |
| Mirjana Kujacic, PHD | AstraZeneca Mölndal, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | London | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Ascending subcutaneous injections of placebo for AZD2820 once daily for 14 days in the abdomen |
|
No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. The QT correction factor will be based on the Fridericia's formula. |
| From baseline, defined as assessment at screening visit and day 1 of dosing. |
| Description of the safety and tolerability profile of AZD2820 in terms of electroencephalography (EEG). | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as mean value of the 10 minutes recording prior first dose up to 7th day of dosing. |
| Description of the safety and tolerability profile of AZD2820 in terms of Columbia-Suicide Severity Rating Scale (C-SSRS). | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as one day prior first dose, up to day 12th of dosing. |
| Description of the safety and tolerability profile of AZD2820 in terms of skin pigmentation. | No formal statistical test will be performed. | From baseline, defined as one day before first dose, up to day 29. |
| Description of the safety and tolerability profile of AZD2820 in terms of Penile erection (measured by Rigiscan). | No formal statistical test will be performed. | From baseline, defined as one day before first dose, up 12th day of dosing. |
| Description of the safety and tolerability profile of AZD2820 in terms of physical examination. | No formal statistical test will be performed. Abnormalities will be listed without statistical analysis. | From baseline, defined as two days prior first dose, up to day 29. |
Maximum drug plasma concentration (Cmax), Area under the drug plasma concentration-time curve from zero to the end of the dosing interval (AUC(0-tau), Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)), Area under the plasma concentration time curve from zero to infinity (AUC), Terminal half-life (t1/2lz, h). |
| Day 1, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs. |
| Description of PK profile of AZD2820 in terms of (Css,max, nmol/L), AUCss,(0-tau), (t1/2lz). | Maximum plasma concentration at steady state (Css,max, nmol/L), Area under the plasma concentration-time curve from zero to the end of the dosing interval at steady state (AUCss,(0-tau)), Terminal half-life (t1/2lz). | Day 7, PK samples collected post-dese at 20 min, 40 min, 1hr, 1.20hr, 1.40hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 18hrs and 24hrs. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |